Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)

Bicarby Dialysate solutions are sterile, single-use dialysis fluids designed for acute kidney replacement therapy in adult patients. Each solution is provided in a 2-compartment bag containing a bicarbonate solution and an electrolyte-glucose solution that are mixed before use to create 5 liters of ready-to-use sterile dialysate. The solutions come in calcium-containing formulations for heparin anticoagulation and calcium-free formulations for regional citrate anticoagulation.

The proposed solutions share the same technological characteristics as the predicate device: identical intended use, indications, design, sterilization method, materials, principle of operation, and performance specifications. The main differences are new ionic contribution formulations and two white hot UDI stamp packaging materials, both of which were previously cleared through related predicate and reference devices (K243786 and K233950).

The devices are classified per FDA guidance document 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' (08 September 2023). Chemical stability testing was performed including appearance, pH, ion concentration, 5-HMF, particulate contamination, sterility, endotoxin, and weight loss analyses.

The proposed Bicarby solutions are substantially equivalent because they use an identical container closure system to the predicate device (K243786), have no changes in patient population or environment of use (adult acute care, <30 days), and previously applicable biocompatibility evaluations remain valid. The new ionic formulations are supported by reference devices' clearances, and chemical stability testing confirms the solutions meet specifications without raising new safety or efficacy concerns.